Refusal Actions by FDA as Recorded in OASIS


   Country of Origin                     Entry #   DOC  Line Suffix
   Manufacture Name
   City / Country or region                                 District
   Product Code        Product Description
                          Date                              Reason
Canada UPS-8006411-0 2 1 Wyeth Canada Saint-laurent QC, CA H4R1J6 NWE-DO 63AIA99 BAZEDOXIFENE FILM COATED TABLETS LAB USE ONLY NOT FOR HUMA 15-AUG-2008 DIRECTIONS LACKS FIRM Canada UPS-8006411-0 1 1 Wyeth Canada Saint-laurent QC, CA H4R1J6 NWE-DO 63AIS99 BAZEDOXIFENE SOLUTION LIQUID LAB RESEARCH ONLY NOT FOR HUMA 15-AUG-2008 DIRECTIONS LACKS FIRM Italy 112-3323105-2 1 1 Sifavitor S.P.A. Lodi (ITALY) , IT 26852 NOL-DO 63BCS26 642502121125 Ipratropium Bromide (Bronchodilator) 01-AUG-2008 UNAPPROVED Israel 112-1620342-5 1 1 Yes Pharma Ltd Bet Shemesh , IL 99100 NOL-DO 63BDZ25 862019115379 FLUTICASONE PROPIONATE 22-AUG-2008 NOT LISTED UNAPPROVED India 411-8164487-7 22 1 Ashiwin Fine Chemical & Pharmaceutical Kashi Mira , IN SWI-DO 63EAL99 KALONJI OIL 18-AUG-2008 NOT LISTED Italy U59-2011266-6 1 1 Inalco S.P.A. Milano MI, IT 20139 NYK-DO 63HBS10 LACTULOSE SOLUTION USP GRADE WITH SORBIC ACID 25-AUG-2008 DIRECTIONS Italy U59-2011283-1 1 1 Inalco S.P.A. Milano MI, IT 20139 NYK-DO 63HBS10 LACTULOSE SOLUTION USP GRADE WITH SORBIC ACID 25-AUG-2008 DIRECTIONS Italy U59-2011283-1 2 1 Inalco S.P.A. Milano MI, IT 20139 NYK-DO 63HBS10 LACTULOSE SOLUTION USP GRADE WITH SORBIC ACID 25-AUG-2008 DIRECTIONS United States DP4-0443664-5 1 1 Colgate Palmolive Co New York, NY 10022 NYK-DO 63RAJ04 TOOTHPASTE 06-AUG-2008 NOT LISTED Thailand 277-0118294-4 11 1 PA- Siam Intertrade Co. Ltd. Bangkok , TH 10120 LOS-DO 63RBY06 TOOTHPASTE HERBAL 27-AUG-2008 NOT LISTED Philippines EBH-0061991-9 49 1 Cosmetic Asia Bulacan , PH SAN-DO 63VAX99 Whitening Herbal Soap 26-AUG-2008 NOT LISTED DRUG NAME UNAPPROVED Switzerland EQ6-0007664-8 1 1 Fcc Frangrances Aigle , CH 1860 FLA-DO 63VAY02 SOAP FDA LABELER CODE# 16541 14-AUG-2008 UNAPPROVED Cameroon N56-0016242-8 1 1 Mbacha Amina Douala , CM NYK-DO 63VAY02 IMMEDIAT CLAIRE Maxi Beauty Lightening Body Cream with Carro 21-AUG-2008 UNAPPROVED Nigeria HD8-0089119-8 1 1 F Vinco Pharmaceuticals UNKNOWN , GB LOS-DO 63VBL02 Lightening Body Oil 05-AUG-2008 NOT LISTED UNAPPROVED China 916-1765327-3 1 1 Spec-Chem Industry Nanjing , CN 210002 NYK-DO 63VCY99 ARBUTIN POWDER B-D-GLUCOPYRANOSIDE, 4-HYDROXY 07-AUG-2008 NOT LISTED DIRECTIONS Germany 101-7869806-3 1 1 Merck Kgaa Darmstadt , DE 64293 NYK-DO 63XAS64 MEGLUMINE LOW IN ENDOTO(NDA PRIOR 1998 ALREADY REVIEWED BY A 21-AUG-2008 DIRECTIONS Germany 101-7869851-9 2 1 Merck Kgaa Darmstadt , DE 64293 NYK-DO 63XAS64 MEGLUMINE LOW IN ENDOTOXINS(NDA PRIOR 1998 ALREADY REVIEWED 21-AUG-2008 DIRECTIONS